ProBio Introduces Fast-Track GMP Plasmid DNA Production in Just 3 Months

• ProBio has launched a GMP plasmid DNA manufacturing service at its Hopewell facility, offering clinical-grade production in as little as three months.

• The new CDMO service includes guaranteed on-time, on-spec delivery, advanced quality controls, and integrated support for gene and cell therapy developers.

ProBio, a global CDMO, has announced the launch of its GMP plasmid DNA manufacturing service at its Hopewell facility. The new offering enables the delivery of clinical-grade plasmid DNA from cell bank to batch release in just three months, which the company states is faster than typical industry timelines.

The service is designed to support gene and cell therapy developers with rapid and dependable access to high-quality plasmid DNA. ProBio guarantees that each batch—whether small-scale (50–200 mg) or gram-level—will meet client specifications, with full transparency and no hidden costs.

“At ProBio, our mission is to redefine reliability and innovation for biopharma partners,” said Allen Guo, CEO of ProBio. “We are committed to raising the bar for the industry and we will deliver at the speed drug developers deserve.”

The Hopewell facility, formerly a biologics research and gene therapy site, now serves as the core of ProBio’s operations. The team employs single-use systems, U.S.-based sourcing, and strict quality control processes to ensure consistent plasmid DNA with ≥85% supercoiled content. According to Chief Quality Officer Ben Chen, the company has embedded quality at every step of its process, from in-house testing and stability studies to environmental monitoring and customisable quality packages.

“Our quality model is intentional and thorough,” said Chen. “We’ve applied best practices from across the industry and aligned our quality systems with regulatory expectations to ensure clients receive dependable GMP plasmids, on time and on specification.”

In addition to rapid turnaround, ProBio’s integrated CDMO capabilities minimise reliance on multiple suppliers. This includes process development, analytical method development, and dedicated project management. Michael Vreeland, Site Head at the Hopewell facility, noted that combining plasmid DNA and future viral vector manufacturing at one site streamlines the process for clients.

“Bringing these services together under one roof means we remove unnecessary bottlenecks,” said Vreeland. “Every step we take is focused on helping our partners advance their programmes more efficiently.”

ProBio expects to further expand its contract manufacturing services, with cGMP AAV production launching by Q3 2025 and cGMP LVV capabilities following in Q1 2026.